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Virus Therapy

CH505w53 for Human Immunodeficiency Virus Infection

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured during screening, and 2 weeks after each vaccination at month 0, 2, 4, and at month 10

Awards & highlights

Study Summary

This trial is testing a new HIV vaccine to see if it is safe and if it causes an immune response in healthy people who do not have HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured during screening, and 2 weeks after each vaccination at month 0, 2, 4, 8, 12, and at month 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured during screening, and 2 weeks after each vaccination at month 0, 2, 4, 8, 12, and at month 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during screening, and 2 weeks after each vaccination at month 0, 2, 4, 8, 12, and at month 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L

Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL

Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils

+27 more

Secondary outcome measures

Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF

Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120

Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding

+15 more

Trial Design

9Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C: Group 9Experimental Treatment3 Interventions

Participants will receive CH505TF at Month 0; CH505w53 at Month 2; and CH505w78 at Months 4.

Group II: Part B: Group 7Experimental Treatment2 Interventions

Participants will receive CH505 M5 (admixed with GLA-SE) at Months 0, 2, 4, and 8.

Group III: Part B: Group 6Experimental Treatment4 Interventions

Participants will receive CH505TF at Month 0; CH505TF and CH505w53 at Month 2; CH505TF, CH505w53, and CH505w78 at Month 4; CH505w53 and CH505w78 at Month 8. GLA-SE adjuvant is admixed with all the CH505 gp120 proteins.

Group IV: Part B: Group 5Experimental Treatment4 Interventions

Participants will receive CH505TF at Month 0; CH505w53 at Month 2; and CH505w78 at Months 4, and 8. GLA-SE adjuvant is admixed with all the CH505 gp120 proteins.

Group V: Part A: Group 3Experimental Treatment2 Interventions

Participants will receive 400 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.

Group VI: Part A: Group 2Experimental Treatment2 Interventions

Participants will receive 100 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.

Group VII: Part A: Group 1Experimental Treatment2 Interventions

Participants will receive 20 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.

Group VIII: Part A: Group 4Placebo Group1 Intervention

Participants will receive placebo at Months 0, 2, 4, 8, and 12.

Group IX: Part B: Group 8Placebo Group1 Intervention

Participants will receive placebo at Months 0, 2, 4, and 8.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CH505w53

2017

Completed Phase 1

~120

CH505 M5

2017

Completed Phase 1

~120

CH505TF

2017

Completed Phase 1

~120

CH505w78

2017

Completed Phase 1

~120

GLA-SE adjuvant

2018

Completed Phase 1

~220

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,268 Previous Clinical Trials

5,481,015 Total Patients Enrolled

Magda SobieszczykStudy ChairColumbia University

James KobieStudy ChairUniversity of Alabama at Birmingham

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many centers are responsible for the oversight of this research project?

"Currently, 5 clinical sites are accepting patient enrolment for this trial. These locations include New york City, Rochester and Boston in addition to 2 other centres. To reduce travel time, it is recommended that participants select the closest site when enrolling."

Answered by AI

What is the approximate number of participants being recruited for this trial?

"Affirmative. The clinicaltrials.gov portal states that this medical trial is actively recruiting participants; the study was initially published on August 22nd 2017 and most recently updated on May 16th 2021. As such, 107 volunteers are needed to be recruited from 5 distinct centres of care."

Answered by AI

Is the recruitment period still open to join this research experiment?

"Affirmative. The information provided by clinicaltrials.gov confirms that this medical trial, which was initially unveiled on August 22nd 2017, is currently enrolling patients. 107 participants need to be recruited from 5 distinct sites."

Answered by AI

Is there an age restriction for participants of this medical experiment?

"This clinical trial seeks participants aged between 18 and 50 years old, while there are 108 studies targeting underage individuals and 353 for seniors."

Answered by AI

Is there an opportunity for me to partake in this research?

"This clinical trial is currently recruiting 107 people with a confirmed HIV diagnosis aged between 18 and 50 years. In order to be eligible for the study, applicants must meet certain criteria, such as being able to demonstrate understanding of the research process through a questionnaire prior to receiving vaccinations; agreeing not to enroll in another investigational research agent before last required protocol clinic visit; consenting to be contacted 6 months after completing scheduled visits; assessed by staff as low risk for HIV infection and committed to maintain "low-risk" behavior until final visit are completed; expressing willingness discuss risks associated with HIV infection and open or receptive towards advice on reducing said risks."

Answered by AI

Has CH505w53 received the official sanction of the Food and Drug Administration?

"As this is an early-stage study, CH505w53 was assigned a rating of 1 due to the dearth of information available on safety and efficacy."

Answered by AI

What is the anticipated outcome of this trial?

"This medical trial has two primary goals. Firstly, it seeks to evaluate the frequency of Serious Adverse Events (SAEs) over 28 months. Secondly, researchers will assess response rates from CD4+ T-cell responses as assessed by ICS assays and monoclonal antibody neutralization activity including evaluating tier 2 virus bnAb action and autologous TF or mutant CH505 viruses through intracellular cytokine staining assessments."

Answered by AI

Recent research and studies

VaccineJournal

Development of a Platform-based Approach for the Clinical Production of HIV Gp120 Envelope Glycoprotein Vaccine Candidates

Wolfe, Leslie S., James G. Smedley III, Niket Bubna, Althaf Hussain, Richard Harper, and Sigma Mostafa. 2021. “Development of a Platform-based Approach for the Clinical Production of HIV Gp120 Envelope Glycoprotein Vaccine Candidates”. Vaccine. Elsevier BV. doi:10.1016/j.vaccine.2021.05.073.

clinicaltrials.govStudy

Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults

2017. "Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03220724.